IDEA4RC FHIR Implementation Guide
0.1.0 - CI Build
150
IDEA4RC FHIR Implementation Guide
0.1.0 - CI Build
150
IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions
| Draft as of 2025-09-10 |
XML representation of the AdverseEvent logical model.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="AdverseEvent"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition AdverseEvent</b></p><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-AdverseEvent-definitions.html#AdverseEvent" title="Adverse Event
Maturity Level: 0 Draft">AdverseEvent</a><a name="AdverseEvent"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://build.fhir.org/types.html#Base">Base</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse Event</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_choice.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Choice of Types" class="hierarchy"/> <a href="StructureDefinition-AdverseEvent-definitions.html#AdverseEvent.treatmentReference[x]" title="Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia
OBSERVATION or CONDITION">treatmentReference[x]</a><a name="AdverseEvent.treatmentReference_x_"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element has obligations">O</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Treatment reference (M)<br/><table class="obligation grid"><tr><td style="font-size: 11px"><b>Obligations</b></td><td style="font-size: 11px"><b>Actor</b></td></tr><tr><td style="font-size: 11px"><b>SHALL</b>:<a href="http://hl7.org/fhir/extensions/5.2.0/CodeSystem-obligation.html#obligation-handle" title="Obligation Codes: correctly handle">handle</a></td><td style="font-size: 11px; opacity: 0.5;"><a href="ActorDefinition-actor-headneck-i4rc.html">Head and Neck</a></td></tr></table></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="Systemic Treatment
Maturity Level: 0 Draft">treatmentReferenceSystemicTreatment</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-SystemicTreatment.html">SystemicTreatment</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="Radiotherapy
Maturity Level: 0 Draft">treatmentReferenceRadiotherapy</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Radiotherapy.html">Radiotherapy</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <span title="Surgery
Maturity Level: 0 Draft">treatmentReferenceSurgery</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Surgery.html">Surgery</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-AdverseEvent-definitions.html#AdverseEvent.adverseEventType" title="the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade
OBSERVATION or CONDITION (check)">adverseEventType</a><a name="AdverseEvent.adverseEventType"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element has obligations">O</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event type (CTCAE Term) (M)<br/><table class="obligation grid"><tr><td style="font-size: 11px"><b>Obligations</b></td><td style="font-size: 11px"><b>Actor</b></td></tr><tr><td style="font-size: 11px"><b>SHALL</b>:<a href="http://hl7.org/fhir/extensions/5.2.0/CodeSystem-obligation.html#obligation-handle" title="Obligation Codes: correctly handle">handle</a></td><td style="font-size: 11px; opacity: 0.5;"><a href="ActorDefinition-actor-headneck-i4rc.html">Head and Neck</a></td></tr></table></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-AdverseEvent-definitions.html#AdverseEvent.adverseEventStartingDate" title="specifies when adverse events begins
OBSERVATION or CONDITION (check)">adverseEventStartingDate</a><a name="AdverseEvent.adverseEventStartingDate"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element has obligations">O</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#date">date</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event starting date (M)<br/><table class="obligation grid"><tr><td style="font-size: 11px"><b>Obligations</b></td><td style="font-size: 11px"><b>Actor</b></td></tr><tr><td style="font-size: 11px"><b>SHALL</b>:<a href="http://hl7.org/fhir/extensions/5.2.0/CodeSystem-obligation.html#obligation-handle" title="Obligation Codes: correctly handle">handle</a></td><td style="font-size: 11px; opacity: 0.5;"><a href="ActorDefinition-actor-headneck-i4rc.html">Head and Neck</a></td></tr></table></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-AdverseEvent-definitions.html#AdverseEvent.adverseEventDuration" title="specifies the duration of the adverse event
OBSERVATION or CONDITION (check)
Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data
https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373">adverseEventDuration</a><a name="AdverseEvent.adverseEventDuration"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element has obligations">O</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event duration (M)<br/><table class="obligation grid"><tr><td style="font-size: 11px"><b>Obligations</b></td><td style="font-size: 11px"><b>Actor</b></td></tr><tr><td style="font-size: 11px"><b>SHALL</b>:<a href="http://hl7.org/fhir/extensions/5.2.0/CodeSystem-obligation.html#obligation-handle" title="Obligation Codes: correctly handle">handle</a></td><td style="font-size: 11px; opacity: 0.5;"><a href="ActorDefinition-actor-headneck-i4rc.html">Head and Neck</a></td></tr></table></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<url
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/AdverseEvent"/>
<version value="0.1.0"/>
<name value="AdverseEventI4RC"/>
<title value="Adverse Event"/>
<status value="draft"/>
<date value="2025-09-10T15:18:34+00:00"/>
<publisher value="IDEA4RC Project"/>
<contact>
<name value="IDEA4RC Project"/>
<telecom>
<system value="url"/>
<value value="https://www.idea4rc.eu/"/>
</telecom>
</contact>
<contact>
<name value="IDEA4RC Project"/>
<telecom>
<system value="url"/>
<value value="https://www.idea4rc.eu/"/>
</telecom>
</contact>
<description value="Adverse Event
Maturity Level: 0 Draft"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="150"/>
<display value="Europe"/>
</coding>
</jurisdiction>
<fhirVersion value="4.0.1"/>
<kind value="logical"/>
<abstract value="false"/>
<type
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/AdverseEvent"/>
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Base"/>
<derivation value="specialization"/>
<snapshot>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
<valueString value="4.0.1"/>
</extension>
<element id="AdverseEvent">
<path value="AdverseEvent"/>
<short value="Adverse Event"/>
<definition value="Adverse Event
Maturity Level: 0 Draft"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Base"/>
<min value="0"/>
<max value="*"/>
</base>
<isModifier value="false"/>
</element>
<element id="AdverseEvent.treatmentReference[x]">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-source">
<valueUri
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/AdverseEvent|0.1.0"/>
</extension>
</extension>
<path value="AdverseEvent.treatmentReference[x]"/>
<short value="Treatment reference (M)"/>
<definition
value="Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia
OBSERVATION or CONDITION"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="AdverseEvent.treatmentReference[x]"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment"/>
</type>
<type>
<code
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy"/>
</type>
<type>
<code
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery"/>
</type>
</element>
<element id="AdverseEvent.adverseEventType">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-source">
<valueUri
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/AdverseEvent|0.1.0"/>
</extension>
</extension>
<path value="AdverseEvent.adverseEventType"/>
<short value="Adverse event type (CTCAE Term) (M)"/>
<definition
value="the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade
OBSERVATION or CONDITION (check)"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="AdverseEvent.adverseEventType"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="AdverseEvent.adverseEventStartingDate">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-source">
<valueUri
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/AdverseEvent|0.1.0"/>
</extension>
</extension>
<path value="AdverseEvent.adverseEventStartingDate"/>
<short value="Adverse event starting date (M)"/>
<definition
value="specifies when adverse events begins
OBSERVATION or CONDITION (check)"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="AdverseEvent.adverseEventStartingDate"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="date"/>
</type>
</element>
<element id="AdverseEvent.adverseEventDuration">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-source">
<valueUri
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/AdverseEvent|0.1.0"/>
</extension>
</extension>
<path value="AdverseEvent.adverseEventDuration"/>
<short value="Adverse event duration (M)"/>
<definition
value="specifies the duration of the adverse event
OBSERVATION or CONDITION (check)
Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data
https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373"/>
<comment
value="Less than one week - 2000100050
More than one week but less than a month - 2000100051
More than a month but less than 3 months - 2000100052
More than 3 months - 2000100053"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="AdverseEvent.adverseEventDuration"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
</element>
</snapshot>
<differential>
<element id="AdverseEvent">
<path value="AdverseEvent"/>
<short value="Adverse Event"/>
<definition value="Adverse Event
Maturity Level: 0 Draft"/>
</element>
<element id="AdverseEvent.treatmentReference[x]">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
</extension>
<path value="AdverseEvent.treatmentReference[x]"/>
<short value="Treatment reference (M)"/>
<definition
value="Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia
OBSERVATION or CONDITION"/>
<min value="1"/>
<max value="*"/>
<type>
<code
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment"/>
</type>
<type>
<code
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy"/>
</type>
<type>
<code
value="http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery"/>
</type>
</element>
<element id="AdverseEvent.adverseEventType">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
</extension>
<path value="AdverseEvent.adverseEventType"/>
<short value="Adverse event type (CTCAE Term) (M)"/>
<definition
value="the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade
OBSERVATION or CONDITION (check)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="AdverseEvent.adverseEventStartingDate">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
</extension>
<path value="AdverseEvent.adverseEventStartingDate"/>
<short value="Adverse event starting date (M)"/>
<definition
value="specifies when adverse events begins
OBSERVATION or CONDITION (check)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="date"/>
</type>
</element>
<element id="AdverseEvent.adverseEventDuration">
<extension url="http://hl7.org/fhir/StructureDefinition/obligation">
<extension url="code">
<valueCode value="SHALL:handle"/>
</extension>
<extension url="actor">
<valueCanonical
value="http://hl7.eu/fhir/ig/idea4rc/actor-headneck-i4rc"/>
</extension>
</extension>
<path value="AdverseEvent.adverseEventDuration"/>
<short value="Adverse event duration (M)"/>
<definition
value="specifies the duration of the adverse event
OBSERVATION or CONDITION (check)
Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data
https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373"/>
<comment
value="Less than one week - 2000100050
More than one week but less than a month - 2000100051
More than a month but less than 3 months - 2000100052
More than 3 months - 2000100053"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
</differential>
</StructureDefinition>
IG © 2022+ IDEA4RC Project. Package hl7.eu.fhir.idea4rc#0.1.0 based on FHIR 4.0.1. Generated 2025-09-10
Links: Table of Contents |
QA Report
The IDEA4RC project has received funding from the European Union's Horizon 2020
research and innovation programme under grant agreement No. 101057048.
